Medical Devices

Natus Medical Incorporated, Olympic Cool-Cap System (Revised)

Recall Class: Class I

Date Recall Initiated: May 9, 2012

Product: Olympic Cool Cap System (Cool Cap)

Catalog/Part Number: 60010

Serial Numbers: All serial numbers are affected by this recall.

Distribution dates: January 18, 2007 through April 20, 2012

Use: The Olympic Cool Cap System (Cool-Cap) is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in full-term infants (at 36 weeks gestational age). A cooling water cap is placed on the infant’s head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling.

The Cool-Cap is used with clinical evidence of moderate to severe HIE. The Cool-Cap provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE.

Recalling Firm:
Natus Medical Incorporated
5900 First Avenue South
Seattle, Washington 98108-3248

Reason for Recall: The Olympic Cool-Caps’ Control Module may experience a frozen screen during treatment. When this occurs, the on-screen information remains on display, but the system is not providing cooling treatment to the infants.

This is a correction to the Natus Olympic Cool-Cap System Class I recall notice that was sent out on December 12, 2012.

Public Contact: Customers with questions about this recall may contact Natus Technical Service at 1-888-496-2887.

FDA District: Seattle District Office

FDA Comments:

On May 16, 2012, Natus Medical Incorporated sent its customers an URGENT: MEDICAL DEVICE letter with an attached Field Safety Notice. The letter describes the product, problem, and the actions taken. Customers can call Natus Technical Service at 1-888-496-2887 for any questions about this recall.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm, by regular mail, by telephone, or by FAX.

Page Last Updated: 02/20/2014
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